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Claims for Patent: 5,972,377

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Claims for Patent: 5,972,377

Title: Transdermal patch and method for administering 17-deacetyl norgestimate alone or in combination with an estrogen
Abstract:Compositions and methods for preventing ovulation in a woman are provided, as well as compositions and methods for female hormone replacement therapy. The compositions can be administered by the use of a transdermal patch. The patch will administer 17-deacetyl norgestimate alone or in combination with an estrogen such as ethinyl estradiol to women.
Inventor(s): Jona; Janan (Sunnyvale, CA), Audett; Jay (Mountain View, CA), Singh; Noel (San Francisco, CA)
Assignee: Cygnus, Inc. (Redwood City, CA)
Application Number:09/165,526
Patent Claims: 1. A transdermal patch for preventing ovulation in a woman comprising:

a) a backing layer; and

b) a non-acrylate containing matrix layer underlying the backing layer, the matrix layer comprising a mixture of 17-deacetyl norgestimate, a skin permeation enhancer selected from the group consisting of a lactate ester of a C.sub.12 to C.sub.18 aliphatic alcohol, and PGML (polyethylene glycol monolaurate), and a pressure sensitive adhesive comprising at least one of a silicone and polyisobutylene, and being adapted to be in diffusional communication with the skin of the woman and to administer an ovulation-inhibiting amount of 17-deacetyl norgestimate.

2. The patch of claim 1 wherein said amount is 150 to 350 .mu.g/day.

3. The patch of claim 1 wherein the pressure-sensitive adhesive consists essentially of polyisobutylene and an aliphatic tackifier.

4. The patch of claim 1 wherein the skin permeation enhancer is lauryl lactate.

5. A transdermal patch for preventing ovulation in a woman comprising:

a) a backing layer; and

b) a non-acrylate containing matrix layer underlying the backing layer, the matrix layer comprising a mixture of 17-deacetyl norgestimate, an estrogen selected from the group consisting of ethinyl estradiol and 17-.beta.-estradiol, a skin permeation enhancer selected from the group consisting of a lactate ester of a C.sub.12 to C.sub.18 aliphatic alcohol, and PGML, and a pressure sensitive adhesive consisting essentially of Polyisobutylene and an aliphatic tackifier, and being adapted to be in diffusional communication with the skin of a woman and to co-administer an ovulation inhibiting amount of 17-deacetyl norgestimate and estrogen to said woman.

6. The patch of claim 5 wherein the estrogen is ethinyl estradiol.

7. The patch of claim 6 wherein said amount is 150 to 350 .mu.g/day of 17-deacetyl norgestimate and from 10 to 35 .mu.g/day of ethinyl estradiol.

8. The patch of claim 5 wherein the estrogen is 17-.beta.-estradiol.

9. The patch of claim 8 wherein said amount is 150 to 350 .mu.g/day of 7-deacetyl norgestimate and from 30-150 .mu.g/day of 17-.beta.-estradiol.

10. The patch of claim 5 wherein the skin permeation enhancer is lauryl lactate.

11. A method of preventing ovulation in a woman comprising affixing to the skin of the woman the transdermal patch of claim 1.

12. The method of claim 11 wherein said amount is 150 to 350 .mu.g/day.

13. A method of preventing ovulation in a woman comprising affixing to the skin of the woman the transdermal patch of claim 5.

14. The method of claim 13 wherein the estrogen is ethinyl estradiol.

15. The method of claim 14, wherein said amount is 150 to 350 .mu.g/day of 17 deacetyl norgestimate and from 10 to 35 .mu.g/day of ethinyl estradiol.

16. A transdermal patch for providing hormone replacement therapy in a woman comprising:

a) a backing layer; and

b) a non-acrylate containing matrix layer underlying the backing layer, the matrix layer comprising a mixture of 17-deacetyl norgestimate, an estrogen selected from the group consisting of ethinyl estradiol and 17-.beta.-estradiol, a skin permeation enhancer selected from the group consisting of a lactate ester of a C.sub.12 to C.sub.18 aliphatic alcohol, and PGML, and a pressure sensitive adhesive consisting essentially of polyisobutylene and an aliphatic tackifier, and being adapted to be in diffusional communication with the skin of a woman and to co-administer a therapeutic amount of 17-deacetyl norgestimate and estrogen to said skin.

17. The patch of claim 16 wherein the estrogen is ethinyl estradiol.

18. The patch of claim 16 wherein the estrogen is 17-.beta.-estradiol.

19. The patch of claim 16 wherein the skin permeation enhancer is lauryl lactate.

20. A method of providing hormone replacement therapy in a woman comprising affixing to the skin of the woman the transdermal patch of claim 16.

21. The method of claim 20 wherein the estrogen is ethinyl estradiol.

22. The patch of claim 3 wherein the tackifier comprises polybutene oil.

23. The patch of claim 3 wherein the matrix layer comprises crosslinked polyvinyl pyrrolidone.

24. The patch of claim 2 wherein the patch transdermally administers 150 to 350 .mu.g/day of 17-deacetyl norgestimate for 7 consecutive days.

25. The patch of claim 5 wherein the tackifier comprises polybutene oil.

26. The patch of claim 6 wherein the matrix layer comprises crosslinked polyvinyl pyrrolidone.

27. The patch of claim 5 wherein the patch transdermally administers 150 to 350 .mu.g/day of 17-deacetyl norgestimate and a therapeutically effective amount of estrogen for 7 consecutive days.

28. The method of claim 12 wherein the pressure sensitive adhesive consists essentially of polyisobutylene and an aliphatic tackifier.

29. The method of claim 12 wherein the matrix transdermally administers 150 to 350 .mu.g/day of 17-deacetyl norgestimate for 7 consecutive days.

30. The method of claim 13 wherein the matrix transdermally administers 150 to 350 .mu.g/day of 17-deacetyl norgestimate and a therapeutically effective amount of estrogen for 7 consecutive days.

31. The patch of claim 16 wherein the tackifier comprises polybutene oil.

32. The patch of claim 16 wherein the matrix layer comprises crosslinked polyvinyl pyrrolidone.

33. The patch of claim 16 wherein the patch transdermally administers 150 to 350 .mu.g/day of 17-deacetyl norgestimate and a therapeutically effective amount of estrogen for 7 consecutive days.
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